Consultation On WHO IP Group Shows Polarised Debate; Challenge For Group

By Tove Iren S. Gerhardsen
Submissions to the World Health Organization (WHO) online public consultation on the intergovernmental working group on public health, innovation and intellectual property show that the debate is quite polarised, and that the group is therefore in for a challenge.

Among the nearly 30 submissions posted to the WHO website within the 1-15 November timeframe, a majority seem to call for alternatives to the current system of using intellectual property rights as the incentive mechanism for medicine research and development, according to the submissions. [Note: There may be more submissions as the WHO said it was also possible to fax submissions.]

The breakout of submissions was fairly evenly divided among industry groups, non-governmental groups, public-private partnerships, academics and others, including at least two governments.

The intergovernmental working group, also referred to as the “IGWG,” was mandated in a resolution agreed to at the World Health Assembly in May (IPW, Public Health, 27 May 2006).

The group has been asked to come up with specific recommendations – including research and development priorities and funding needs – as to how medicines for diseases that “disproportionately affect developing countries” may be ensured in the future.

The group must develop a “global strategy and plan of action in order to provide a medium-term framework on the recommendations of the Commission [on Intellectual Property Rights, Innovation and Public Health],” according to the resolution. The CIPIH published its report with some 60 recommendations in May this year.

The WHO appointed Howard Zucker and Elil Renganathan to be in charge of the group from the WHO side, but as it will be run by the WHO member states, the group will be formally set up at a 4-8 December. The submissions will be pulled together and presented at this meeting, the WHO said.

The submissions to the online consultation may be divided roughly into two groups: Those who propose finding the solution to the issue within the current intellectual property system, and those who want an alternative system.

A number of submissions say that the working group should consider a proposal to establish a Medical Prize Fund, an idea developed by James Love of the Consumer Project on Technology, among others. This would encourage new incentive systems not “tied directly to high drug prices,” but defraying research costs through government contributions to prize funds that would give grants to pharmaceutical companies that develop “inventions that were voluntary licensed to patent pools,” Love said in his submissions.

A number of non-governmental organisations as well as academics seem to support this or similar ideas, according to the submissions, but the pharmaceutical industry and the public private partnerships argue that no other incentive than intellectual property rights will work. The International AIDS Vaccine Initiative, for example, suggests that the global strategy should “create incentive measures for industry with embedded IP provisions.”

Many of the submissions are directly related to the CIPIH report recommendations. For example, some like the AIDS Vaccine Advocacy Coalition, point out the importance of focusing on the specific needs and requirements for vaccine development. A number of submissions also highlight the importance of a resolution from Kenya and Brazil on which the Health Assembly resolution was based.

The Role of the WHO

On the role of the WHO, some provided the recommendation for the working group or the WHO to focus on boosting public-private partnerships (PPPs).

“WHO should consider whether it could act as a catalyst to form (or consolidate) PPPs (and necessary funding for their activities) for these neglected diseases and to encourage more fundamental research in universities and research institutions worldwide,” said Trevor Jones, former commissioner of the CIPIH and founder of the PPP Medicines for Malaria Venture.

Another submission favours “WHO-mediated voluntary license agreements,” which means that deals are reached with the holder of the intellectual property rights of a product, to pre-empt the issuance of a compulsory license.

Yet others call for the WHO to engage with the World Trade Organization regarding the implementation of the public health-related provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The European Generic Medicines Association sought engagement with the World Intellectual Property Organization (WIPO) to ensure “quality of patents.”

A number of submissions also argue that the group should evaluate the impact of bilateral free trade agreements and TRIPS provisions on medicine development and access.

What Constitutes Neglected Diseases?

There seems to be some disparity as to which diseases the group will focus on, with “(truly) neglected diseases,” “tropical diseases” and “diseases of poverty” among the many terms used. Some call specifically for the inclusion of non-communicable diseases on the agenda, and at least one, Ellen‘t Hoen, Médicins Sans Frontières, said the group should not limit itself to neglected disease as “the problem is wider in scope.”

Many submissions welcomed the intergovernmental working group, while only one from the free-market International Policy Network states directly that, “Governments should not create a new intergovernmental body for drug development as it would likely be inefficient and would divert resources away from more productive uses.”

Nicoletta Dentico of the Drugs for Neglected Diseases Initiative said that the working group provides a “huge opportunity” which could “bravely mark the follow-up of the essential drugs policy work that the WHO pursued in the 1970s.”

Tove Iren S. Gerhardsen may be reached at tgerhardsen@ip-watch.ch.